Polymeric compositions for medical packaging and devices

ABSTRACT

Multiple component polymer compositions for fabrication into articles. In particular, polymeric compositions comprising a heat resistant polymer; a radio frequency (“RF”) susceptible polymer; a compatibilizing polymer; the composition having physical properties within a range a&lt;40,000 psi; b&gt;=70%; c&lt;30%; d&gt;1.0; e&lt;0.1%; f&lt;0.1%; g&gt;=0.05; h&lt;=60%; i=0; wherein: a is the mechanical modulus of the composition measured according to ASTM D-882; b is the percent recovery in length of the composition after an initial 20% deformation; c is the optical haze of the composition being 9 mils in thickness according to ASTM D-1003; d is the loss tangent of the composition at 1 Hz measured at melt processing temperatures; e is the elemental halogen content by weight of the composition; f is the low molecular weight water soluble fraction of the composition; g is the dielectric loss between 1 and 60 MHz and over temperatures of 25 to 250° C. of the composition; h sample creep measured at 121° C. for a 1 inch strip of the composition under 27 psi loading; and, i indicates the composition exhibits no strain whitening after being strained at moderate speeds of about 20 inches (50 cm) per minute to about 100% elongation (twice the original length) and the presence of strain whitening (indicated by 1) or lack thereof (indicated by 0) is noted.

This application is a divisional of U.S. application Ser. No. 08/153,823filed Nov. 16, 1993, now U.S. Pat. No. 5,849,843.

DESCRIPTION

1. Technical Field

The present invention relates generally to thermoplastic polymer alloysfor fabricating into films, containers, tubing, and other devices.

2. Background Prior Art

In the medical field, where beneficial agents are collected, processedand stored in containers, transported, and ultimately delivered throughtubes by infusion to patients to achieve therapeutic effects, materialswhich are used to fabricate the containers and tubes must have a uniquecombination of properties. For example, in order to visually inspectsolutions for particulate contaminants, the container or tubing must beoptically transparent. To infuse a solution from a container bycollapsing the container walls, without introducing air into thecontainer, the material which forms the walls must be sufficientlyflexible. The material must be functional over a wide range oftemperatures. The material must function at low temperatures bymaintaining its flexibility and toughness because some solutions, forexample, certain premixed drug solutions are stored and transported incontainers at temperatures such as −25 to −30° C. to minimize the drugdegradation. The material must also be functional at high temperaturesto withstand the heat of sterilization; a process which most medicalpackages and nutritional products are subjected to prior to shipment.The sterilization process usually includes exposing the container tosteam at temperatures typically 121° C. and at elevated pressures. Thus,the material needs to withstand the temperature and pressures withoutsignificant distortions (“heat distortion resistance”).

For ease of manufacture into useful articles, it is desirable that thematerial be sealable using radio frequency (“RF”) generally at about27.12 MHz. Therefore, the material should possess sufficient dielectricloss properties to convert the RF energy to thermal energy.

A further requirement is to minimize the environmental impact upon thedisposal of the article fabricated from the material after its intendeduse. For those articles that are disposed of in landfills, it isdesirable to use as little material as possible and avoid theincorporation of low molecular weight leachable components to constructthe article. Thus, the material should be light weight and have goodmechanical strength. Further benefits are realized by using a materialwhich may be recycled by thermoplastically reprocessing thepost-consumer article into other useful articles.

For those containers which are disposed of through incineration, it isnecessary to use a material which helps to eliminate the dangers ofbiological hazards, and to minimize or eliminate entirely the formationof inorganic acids which are environmentally harmful, irritating, andcorrosive, or other products which are harmful, irritating, or otherwiseobjectionable upon incineration.

It is also desirable that the material be free from or have a lowcontent of low molecular weight additives such as plasticizers,stabilizers and the like which could be released into the medications orbiological fluids or tissues thereby causing danger to patients usingsuch devices or are contaminating such substances being stored orprocessed in such devices. For containers which hold solutions fortransfusion, such contamination could make its way into the transfusionpathway and into the patient causing injury or death to the patient.

Traditional flexible polyvinyl chloride materials meets a number of, andin some cases, most of the above-mentioned requirements. Polyvinylchloride (“PVC”) also offers the distinct advantage of being one of themost cost effective materials for constructing devices which meet theabove requirements. However, PVC may generate objectionable amounts ofhydrogen chloride (or hydrochloric acid when contacted with water) uponincineration, causing corrosion of the incinerator. PVC sometimescontains plasticizers which may leach into drugs or biological fluids ortissues that come in contact with PVC formulations. Thus, many materialshave been devised to replace PVC. However, most alternate materials aretoo expensive to implement and still do not meet all of the aboverequirements.

There have been many attempts to develop a film material to replace PVC,but most attempts have been unsuccessful for one reason or another. Forexample, in U.S. Pat. No. 4,966,795 which discloses multilayer filmcompositions capable of withstanding the steam sterilization, cannot bewelded by radio frequency dielectric heating thus cannot be assembled bythis rapid, low costs, reliable and practical process. EuropeanApplication No. EP 0 310 143 A1 discloses multilayer films that meetmost of the requirements, and can be RF welded. However, components ofthe disclosed film are cross-linked by radiation and, therefore, cannotbe recycled by the standard thermoplastic processing method. Inaddition, due to the irradiation step, appreciable amounts of aceticacid is liberated and trapped in the material. Upon steam sterilization,the acetic acid migrates into the packaging contents as a contaminantand by altering the pH of the contents acts as a potential chemicalreactant to the contents or as a catalyst to the degradation of thecontents.

The main objective of the present invention is the creation ofthermoplastic materials which are, overall, superior to those materials,of which we are aware, which have been heretofore known to the art orhave been commercially used or marketed. The properties of suchmaterials includes flexibility, extensibility, and strainrecoverability, not just at room temperatures, but through a wide rangeof ambient and refrigerated temperatures. The material should besufficiently optically transparent for visual inspection, and steamsterilizable at temperatures up to 121° C. The material should becapable of being subjected to significant strains without exhibitingstrain whitening, which can indicate a physical and a cosmetic defect. Afurther objective is that the material be capable of assembly by the RFmethods. Another objective is that the material be without low molecularweight leachable additives, and be capable of safe disposal byincineration without the generation of significant amounts of corrosiveinorganic acids. Another objective is that the material be recyclable bystandard thermoplastic processing methods after use. It is alsodesirable that the material incorporate reground scrap materialrecovered during the manufacturing process to save material costs.Finally, the material should serve as a cost effective alternative tovarious PVC formulations currently being used for medical devices.

When more than one polymer is blended to form an alloying composition,it is difficult to achieve all of the above objectives simultaneously.For example, in most instances alloy composition scatter light; thus,they fail to meet the optical clarity objective. The light scatteringintensity (measured by haze) depends on the domain size of components inthe micrometer (μ) range, and the proximity of the refractive indices ofthe components. As a general rule, the selection of components that canbe satisfactorily processed into very small domain sizes, and yet with aminimum of refractive index mismatches, is a difficult task.

The present invention is provided to solve these and other problems.

SUMMARY OF THE INVENTION

In accordance with the present invention certain thermoplastic polymercompositions have been developed which are substantial improvements tocompositions and articles of which we are aware. These compositions maybe fabricated into medical grade articles such as bags for storingmedical fluids or may be used to make other products or components offinished products such as connectors, adaptors, manifolds, valves,conduits, catheters, and etc.

It is an object of the present invention to prepare a composition havingthe following physical properties: (1) a mechanical modulus less than40,000 psi and more preferably less than 25,000 when measured inaccordance with ASTM D-882, (2) a greater than or equal to 70%, and morepreferably greater than or equal to 75%, recovery in length after aninitial deformation of 20%, (3) and optical haze of less than 30%, andmore preferably less than 15%, when measured for a composition 9 milsthick and in accordance to ASTM D-1003, (4) the loss tangent measured at1 Hz at processing temperatures is greater than 1.0, and more preferablygreater than 2.0, (5) the content of elemental halogens is less than0.1%, and more preferably less than 0.01%, (6) the low molecular weightwater soluble fraction is less than 0.1%, and more preferably less than0.005%, (7) the maximum dielectric loss between 1 and 60 MHz and betweenthe temperature range of 25-250° C. is greater than or equal to 0.05 andmore preferably greater than or equal to 0.1, (8) autoclave resistancemeasured by sample creep at 121° C. under 27 psi loading is less than orequal to 60% and more preferably less than or equal to 20%, and (9)there is no strain whitening after being strained at moderate speeds ofabout 20 inches (50 cm) per minute at about 100% elongation and thepresence of strain whitening is noted or the lack thereof.

The polymer based compositions of the present invention that satisfythese physical properties comprise multiple component compositions.Three component compositions consists of a first component of a flexiblepolyolefin that confers heat resistance and flexibility, a secondcomponent of a RF susceptible polymer that renders the film RF sealable,and a third component that confers compatibility between the first twocomponents. The RF susceptible polymers of the present invention, whichwill be set forth in detail below, should have a dielectric loss ofgreater than 0.05 at frequencies within the range of 1-60 MHz within atemperature range of ambient to 250° C. The first component shouldconstitute within a range of 40-90% by weight of the composition, thesecond component should constitute within the range of 5-50% by weightof the composition, and the third component should constitute 5-30% byweight of the composition.

In another embodiment of the three component composition, the firstcomponent confers high temperature resistance, the second component isan RF susceptible polymer that renders the composition RF sealable andconfers flexibility to the film, and the third component serves as acompatabilizer between the first two components. The first componentshould constitute within the range of 30-60%, the second component30-60%, and the third component 5-30% by weight of the composition.

Four component compositions include a first propylene based polyolefin,which may include isotactic and syndiotactic stereo isomers, a secondnon-propylene based polyolefin, a third component of a RF susceptiblepolymer that renders the compositions RF sealable, and a compatibilizingpolymer. Preferably the first polyolefin is polypropylene whichconstitutes approximately 30-60% by weight of the compositions, and mostpreferably 45%. The second polyolefin is preferably an ultra low densitypolyethylene or polybutene-1 which constitute approximately 25-50% byweight of the compositions, and most preferably 45%. The RF component ispreferably a dimer fatty acid polyamide (which should be interpreted toinclude their hydrogenated derivatives as well), which constitutesapproximately 3-40% by weight of the compositions, and most preferably10%. The fourth component is a compatibilizing polymer that may beselected from various block copolymers of styrene with dienes or alphaolefins; the compatibilizing polymers may be modified with minor amountsof chemically active functionalities. For example, the compatibilizingpolymer may be a styrene ethylene-butene styrene (“SEBS”) blockcopolymers. The fourth component should constitute between 5-40% byweight of the composition and most preferably 10%.

These three and four component compositions each may be compounded andextruded to form a thin film which is RF active so that it is RFsealable to itself. For example, films and tubings may be used toproduce sterile fluid packages, containers for blood and bloodcomponents, intravenous and medical solutions, nutritional andrespiratory therapy products, as well as dialysis solutions. Thecompositions may also be used to construct port tubes and access devicesfor containers. The compositions may also be used to form other productsthrough injection molding, blow molding, thermoforming, or other knownthermoplastically processing methods.

The compositions are compatible with medical applications because thecomponents which constitute the film have a minimal extractability tothe fluids and contents that the composition come in contact with.Further, the films are environmentally sound in that they do notgenerate harmful degradants upon incineration. Finally, the filmsprovide a cost effective alternative to PVC.

Additional features and advantages of the present invention aredescribed in, and will be apparent from the detailed description of thepresently preferred embodiments.

DETAILED DESCRIPTION

While this invention is susceptible of embodiments in many differentforms, and will herein be described in detail, preferred embodiments ofthe invention are disclosed with the understanding that the presentdisclosure is to be considered as exemplifications of the principles ofthe invention and are not intended to limit the broad aspects of theinvention to the embodiments illustrated.

More particularly, according to the present invention it is desirable toprovide compositions which may be thermoplastically fabricated intoarticles, devices, and products, which meet the requirements set forthabove.

To this end, as noted above, it has been found that material havingthese characteristics can be prepared from compositions havingpreferably three, four or more components. The three and four componentcompositions will be discussed separately below.

Three Component Compositions

In a first embodiment of a three component system, the first componentwill confer heat resistance and flexibility to the composition. Thiscomponent may be chosen from the group consisting of amorphous polyalphaolefins and preferably is a flexible polyolefin. These polyolefinsshould resist distortions to high temperatures up to 121° C., having apeak melting point of greater than 130° C. and be highly flexible,having a modulus of not more than 20,000 psi. Such a flexible polyolefinis sold under the product designation Rexene FPO 90007 which has a peakmelting point of 145° C. and a modulus of 11,000 psi. In addition,certain polypropylenes with high syndiotacticity also posses theproperties of high melting point and low modulus. The first componentshould constitute by weight within the range of 40-90% by weight of thecomposition.

The second component of the three component composition is an RFsusceptible polymer which confers RF sealability to the composition andmay be selected from either of two groups of polar polymers. The firstgroup consists of ethylene copolymers having 50-85% ethylene contentwith comonomers selected from the group consisting of acrylic acid,methacrylic acid, ester derivatives of acrylic acid with alcohols having1-10 carbons, ester derivatives of methacrylic acid with alcohols having1-10 carbons, vinyl acetate, and vinyl alcohol. The RF susceptiblepolymer may also be selected from a second group consisting ofcopolymers containing segments of polyurethane, polyester, polyurea,polyimide, polysulfones, and polyamides. These functionalities mayconstitute between 5-100% of the RF susceptible polymer. The RFsusceptible polymer should constitute by weight within the range of5-50% of the composition. Preferably, the RF component is copolymers ofethylene methyl acrylate with methyl acrylate within the range of 15-25%by weight of the polymer.

The final component of the three component compound ensurescompatibility between the first two components, and is selected from anstyrenic block copolymers and preferably is maleic anhydridefunctionalized. The third component should constitute by weight withinthe range of 5-3% of the composition.

In a second embodiment of the three component film, the first componentconfers RF sealability and flexibility over the desired temperaturerange. The first component confers high temperature resistance(“temperature resistant polymer”) and is chosen from the groupconsisting of polyamides, polyimides, polyurethanes, polypropylene andpolymethylpentene. Preferably the first component constitutes by weightwithin the range of 30-60% of the composition, and preferably ispolypropylene. The second component confers RF sealability andflexibility over the desired temperature range. The RF polymer isselected from the first and second groups identified above with theexception of ethylene vinyl alcohol. The second component shouldconstitute by weight within the range of 30-60% of the composition.

The third component ensures compatibility between the first twocomponents and is chosen from SEBS block copolymers and preferably ismaleic anhydride functionalized. The third component should constitutewithin the range of 5-30% by weight of the composition.

Four Component Compositions

The first component of the four component film is to confer heatresistance. This component may be chosen from polyolefins, mostpreferably polypropylenes, and more specifically the propylenealpha-olefin random copolymers (PPE). Preferably, the PPE's will have anarrow molecular weight range. The PPE's possess the required rigidityand the resistance to yielding at the autoclave temperatures of about121° C. However, by themselves, the PPE's are too rigid to meet theflexibility requirements. When combined by alloying with certain lowmodulus polymers, good flexibility can be achieved. Examples ofacceptable PPE's include those sold under the product designationsSoltex 4208, and Exxon Escorene PD9272.

These low modulus copolymers can include ethylene based copolymers suchas ethylene-co-vinyl acetate (“EVA”), ethylene co-alpha olefins, or theso-called ultra low density (typically less than 0.90 Kg/L)polyethylenes (“ULDPE”). These ULDPE include those commerciallyavailable products sold under the trademarks TAFMER® (MitsuiPetrochemical Co.) under the product designation A485, Exact® (ExxonChemical Company) under the product designations (4023-4024, and Insite®technology polymers (Dow Chemical Co.). In addition, poly butene-1(“PB”), such as those sold by Shell Chemical Company under productdesignations PB-8010, PB-8310; thermoplastic elastomers based on SEBSblock copolymers, (Shell Chemical Company), poly isobutene (“PIB”) underthe product designations Vistanex L-80, L-100, L-120, L-140 (ExxonChemical Company), ethylene alkyl acrylate, the methyl acrylatecopolymers (“EMA”) such as those under the product designation EMAC2707, and DS-1130 (Chevron), and n-butyl acrylates (“ENBA”) (QuantumChemical) were found to be acceptable copolymers. Ethylene copolymerssuch as the acrylic and methacrylic acid copolymers and their partiallyneutralized salts and ionomers, such as PRIMACOR® (Dow Chemical Company)and SURYLN® (E.I. DuPont de Nemours & Company) were also satisfactory.Typically, ethylene based copolymers have melting points of less thanabout 110° C. are not suited for autoclaving applications. Further, aswill be shown in certain of the below counter examples (eg., Example8G), not all the alloying pairs are optically clear to qualify for thevisual inspection requirement. Furthermore, only a limited range ofproportions of each component allows the simultaneous fulfillment of theflexibility and autoclavability requirements.

Preferably the first component is chosen from the group of polypropylenehomo and random copolymers with alpha olefins which constitute by weightapproximately 30-60%, more preferably 35-45%, and most preferably 45%,of the composition. For example, random copolymers of propylene withethylene where the ethylene content is in an amount within the range of0-6%, and more preferably 2-4%, of the weight of the polymer ispreferred as the first component.

The second component of the four component composition confersflexibility and low temperature ductility and is a second polyolefindifferent than that of the first component wherein it contains nopropylene repeating units (“non propylene based polyolefin”). Preferablyit is ethylene copolymers including ULDPE, polybutene, butene ethylenecopolymers, ethylene vinyl acetate, copolymers with vinyl acetatecontents between approximately 18-50%, ethylene methyl acrylatecopolymers with methyl acrylate contents being between approximately20-40%, ethylene n-butyl acrylate copolymers with n-butyl acrylatecontent of between 20-40%, ethylene acrylic acid copolymers with theacrylic acid content of greater than approximately 15%. An example ofthese products are sold under such product designations as Tafmer A-4085(Mitsui), EMAC DS-1130 (Chevron), Exact 4023, 4024 and 4028 (Exxon).More preferably, the second component is either ULDPE sold by MitsuiPetrochemical Company under the designation TAFMER A-4085, orpolybutene-1, PB8010 and PB8310 (Shell Chemical Co.), and shouldconstitute by weight approximately 25-50%, more preferably 35-45%, andmost preferably 45%, of the composition.

To impart RF dielectric loss to the four component composition, certainknown high dielectric loss ingredients (“RF susceptible polymers”) areincluded in the composition. These polymers may be selected from thegroup of RF polymers in the first and second group set forth above.

Other RF active materials include PVC, vinylidine chlorides, andfluorides, copolymer of bis-phenol-A and epichlorohydrines known asPHENOXY® (Union Carbide). However, significant contents of thesechlorine and fluorine containing polymers would render the compositionenvironmentally unsound as incineration of such a material wouldgenerate inorganic acids.

The polyamides of the RF susceptible polymer are preferably selectedfrom aliphatic polyamides resulting from the condensation reaction ofdi-amines having a carbon number within a range of 2-13, aliphaticpolyamides resulting from a condensation reaction of di-acids having acarbon number within a range of 2-13, polyamides resulting from thecondensation reaction of dimer fatty acids, and amides containingcopolymers (random, block, and graft). Polyamides such as nylons arewidely used in thin film material because they offer abrasion resistanceto the film. However, rarely are the nylons found in the layer whichcontacts medical solutions as they typically contaminate the solution byleaching out into the solution. However, it has been found by theApplicants of the present invention that the most preferred RFsusceptible polymer are a variety of dimer fatty acid polyamides sold byHenkel Corporation under the product designations MACRO-MELT andVERSAMID, which do not lead to such contamination. The RF susceptiblepolymer preferably should constitute by weight approximately 5-30%, morepreferably between 7-13%, and most preferably 10%, of the composition.

The fourth component of the composition confers compatibility betweenthe polar and nonpolar components of the composition (sometimes referredto as a “compatibilizing polymer”) and preferably is styrenic blockcopolymers with hydrocarbon soft segments. More preferably, the fourthcomponent was chosen from SEBS block copolymers that are modified bymaleic anhydride, epoxy, or carboxylate functionalities, and preferablyis an SEBS block copolymer that contains maleic anhydride functionalgroups (“functionalized”). Such a product is sold by Shell ChemicalCompany under the designation KRATON RP-6509. The compatibilizingpolymer should constitute by weight approximately 5-40%, more preferably7-13%, and most preferably 10% of the composition.

It may also desirable to add a fifth component of a nonfunctionalizedSEBS block copolymer such as the ones sold by Shell Chemical Companyunder the product designations KRATON G-1652 and G-1657. The fifthcomponent should constitute by weight approximately 5-40%, morepreferably 7-13%, and most of the composition.

For each of the compositions set forth above, it may be desirable toadd, in trace amounts, other additives such as slip agents, lubricants,waxes, and antiblocks as is needed and as is well known in the art aslong as the final composition meets the physical requirements set forthabove.

The above multiple component compositions may be processed to make avariety of porducts such as a film. Such film may be made using severaltechniques well known in the industry. For example, the above componentsmay be blended in the dry form in a high intensity blender such as aWelex blender and fed into an extruder. The components may also begravimetrically fed into a high intensity mixing extruder of the twinscrew design, such as a Werner Pfleiderer, and the output may bequenched in multiple strands in a water bath, pelletized, and dried foruse. The pelletizing step may be avoided in a third method by feedingthe output of the compounding extruder directly into a film extruder. Itis also possible to build into a film extruder a high intensity mixingsection so that an alloy film may be produced using a single extruder.The alloy may be converted into other articles and shapes using otherthermoplastic converting machines such as injection molding or injectionblow molding machines. Of course there are many other known methods ofprocessing alloys into film, and the present invention should not belimited to producing a film by these exemplary methods.

Compositions having a various components and weight percentages setforth in the below examples were fabricated into films and tested usingthe following methods.

(1) AUTOCLAVABILITY:

Autoclave resistance is measured by sample creep, or the increase in thesample length, at 121° C. under 27 psi loading for one hour. Theautoclave resistance must be less than or equal to 60%.

(2) LOW AND AMBIENT TEMPERATURE DUCTILITY:

(A) Low Temperature Ductility

In an instrumented impact tester fitted with a low temperatureenvironmental chamber cooled with liquid nitrogen, film samples about 7by 7 inches (18 cm by 18 cm) are mounted onto circular sample holdersabout 6 inches (15 cm) in diameter. A semi-spherical impact head withstress sensors is driven at high velocities (typically about 3 m/sec)into the preconditioned film loading it at the center. Thestress-displacement curves are plotted, and the energy of impact iscalculated by integration. The temperature at which the impact energyrises dramatically, and when the fractured specimen changes from brittleto ductile, high strain morphology is taken as a measure of the lowtemperature performance of the film (“L.Temp”).

(B) Mechanical Modulus and Recovery:

The autoclaved film sample with a known geometry is mounted on aservohydraulically driven mechanical tester having cross heads toelongate the sample. At 10 inches (25 cm) per minute crosshead speed,the sample is elongated to about 20% elongation. At this point, thecross-heads travel and then reverse to travel in a direction oppositethat originally used to stretch the sample. The stress strain behavioris recorded on a digital recorder. The elastic modulus (“E(Kpsi)”) istaken from the initial slope on the stress-strain curve, and therecovery taken from the excess sample dimension as a percentage ofsample elongation.

(3) RF PROCESSIBILITY:

Connected to a Callanan 27.12 MHz, 2 KW Radio Frequency generator, is arectangular brass die of about 0.25 (6.3 mm) by 4 inches (10 cm)opposing to a flat brass electrode, also connected to the generator.Upon closing the die with two sheets of the candidate material inbetween, RF power of different amplitudes and durations are applied.When the RF cycle is over, the die is opened and the resultant sealexamined by manually pulling apart the two sheets. The strength of theseal (versus the film strength) and the mode of failure (peel, tear, orcohesive failures) are used to rate the RF responsiveness of thematerial.

Alternatively, the candidate film is first sputter coated with gold orpalladium to a thickness of 100 angstroms to render the surfaceconductive, cut into a circular geometry and mounted between theparallel electrodes in a dielectric capacitance measuring cell. Using aHewlett Packard 4092 automatic RF bridge, the dielectric constant andthe dielectric losses are measured at different frequencies up to 10 MHzand temperatures up to 150° C. The dielectric loss allows thecalculation of heat generation under an RF field. From calculations orcorrelations with RF seal experiments the minimum dielectric loss forperformance is obtained.

If the RF seal performance is obtained from the Callanan sealer, thefollowing ranking scale is adopted:

RF Power RF Time Seal Strength Rating 80% 10 No 0 80% 10 Peelable 1 80%05 Peelable 2 60% 03 Strong 3 50% 03 Strong 4 30% 03 Strong 5(4) OPTICAL CLARITY:

Post autoclaved film samples are first cut into about 2 by 2 inches (5by 5 cms) squares, mounted on a Hunter Colorimeter and their internalhaze measured according to ASTM D-1003. Typically, internal haze levelof less than 30% is required, preferably less than 20% for thesethicknesses (“Haze %”).

(5) STRAIN WHITENING:

The autoclaved film is strained at moderate speeds of about 20 inches(50 cm) per minute to about 100% elongation (twice the original length)and the presence (indicated by 1) of strain whitening or lack thereof(indicated by 0) is noted (“S.Whitening”).

(6) ENVIRONMENTAL COMPATIBILITY:

The environmental compatibility comprises three important properties:(a) the material is free of low molecular weight plasticizers whichcould leach into landfills upon disposal, (2) the material can bethermoplastically recycled into useful items upon fulfilling the primarypurpose of medical delivery, and (3) when disposed of by energy reclaimby incineration, no significant inorganic acids are released to harm theenvironment. (“Envir.”). The composition will also contain less than0.1% halogens by weight. In order to facilitate recycling by meltprocessing, the resultant composition should have a loss tangent greaterthan 1.0 at 1 Hz measured at processing temperatures.

(7) SOLUTION COMPATIBILITY

By solution compatibility we mean that a solution contained within thefilm is not contaminated by components which constitute the composition.(“S.Comp.”) The low molecular weight water soluble fraction of thecomposition will be less than 0.1%.

The following combinations were tested using the above test for threeand four component compositions. The examples demonstrate certainunexpected advantages obtained with these compositions.

EXAMPLE 1

(1) Four and five component compositions, PPE, PE Copolymers, ModifiedSEBS, and RF Active Polymer. S. Auto- Haze Whit- L. Comp. clav (%)E(Kpsi) RF ening Temp Envir. S.Comp. A Yes 29 45 4 0 −30 Yes Yes B Yes20 35 4 0 −40 Yes Yes C Yes 20 35 4 0 −25 Yes Yes D Yes 25 35 4 0 −25Yes Yes E Yes 15 25 4 0 −40 Yes Yes F Yes 15 25 4 0 −40 Yes Yes G Yes 1525 4 0 −40 Yes Yes H Yes 20 25 3 0 −40 Yes Yes I Yes 25 22 3 0 −40 YesYes A. 60% Soltex 4208, 20% Mitsui Tafmer A-4085, 15% Kraton RP6509, 5%PA-12. B. 50% Soltex 4208, 30% Tafmer A-4085, 15% Kraton G1657, 5%PA-12. C. 50% Soltex 4208, 30% Chevron EMAC DS1130, 10% Kraton RP6509,10% Henkel MM-6301. D. 50% Soltex 4208, 30% EMAC-DS1130, 10% KratonRP6509, 5% PEU-103-200, 5% MM-6301. E. 45% Soltex 4208, 35% TafmerA-4085, 10% Kraton RP6509, 10% Henkel MM-6239. F. 45% Soltex 4208, 35%Exxon EXACT4028, 10% Kraton RP6509, 10% MM-6301. G. 45% Soltex 4208, 35%Exact-4024, 10% Kraton RP6509, 10% MM-6301. H. 45% Soltex 4208, 35%Exact-4023, 10% Kraton RP6509, 10% MM-6301. I. 40% Soltex 4208, 40%Tafmer A-4085, 10% Kraton RP6509, 10% Poly Vinyl Acetate (40% HydrolyzedMW = 72,000).

EXAMPLE 2

(2) Four Component Compositions: PPE, Polybutene-1(copolymers), ModifiedSEBS, and Polyamide alloys. S. Auto- Haze Whit- L. Comp. clav (%)E(Kpsi) RF ening Temp Envir. S.Comp. A Yes 15 40 4 0 −20 Yes Yes B Yes20 40 4 0 −20 Yes Yes C Yes 20 30 4 0 −20 Yes Yes D Yes 20 30 4 0 −20Yes Yes E Yes 15 30 4 1 −20 Yes Yes F Yes 15 30 4 1 −20 Yes Yes G Yes 2030 4 1 −20 Yes Yes A. 55% Soltex 4208, 35% Shell PB8010, 10% 5% KratonRP6509, 5% L-20. B. 55% Soltex 4208, 25% PB-8310, 10% Kraton RP6509, 10%Henkel MM-6301. C. 45% Soltex 4208, 35% PB-8310, 10% Kraton RP6509, 10%MM-6239. D. 45% Exxon Escorene PD9272, 35% PB-8010, 10% Kraton RP6509,10% MM-6301. E. 45% Soltex 4208, 35% PB-8010, 10% Kraton RP6509, 10%MM-6301. F. 45% Soltex 4208, 35% PB-8010, 10% Kraton RP6509, 10%Uni-Rez2633. G. 45% Soltex 4208, 35% PB-8310, 10% Kraton RP6509, 10%MM-6301.

EXAMPLE 3

(3) Four Component Compositions: PPE, Polyisobutene, Modified SEBS, andPolyamide alloys. S. Auto- Haze Whit- L. Comp. clav (%) E(Kpsi) RF eningTemp Envir. S.Comp. A Yes 35 40 3 1 −30 Yes Yes B Yes >50 30 3 1 −30 YesYes C Yes 35 30 4 1 −25 Yes Yes D Yes 40 30 4 1 −25 Yes Yes E Yes >40 304 1 −25 Yes Yes F Yes >40 30 4 1 −25 Yes Yes A. 50% Soltex 4208, 30%Exxon Vistanex L120, 5% Kraton RP6509, 10% Kraton G-1657, 5% PA-12. B.35% Soltex 4208, 45% Vistanex L120, 15% Kraton RP6509, 5% PA-12. C. 45%Soltex 4208, 35% Vistanex L-80, 10% Kraton RP6509, 10% Henkel MM-6301.D. 45% Soltex 4208, 35% Vistanex L-100, 10% Kraton RP6509, 10% HendelMM-6301. E. 45% Soltex 4208, 35% Vistanex L120, 10% Kraton RP6509, 10%Henkel MM-6301. F. 45% Soltex 4208, 35% Vistanex L-140, 10% KratonRP6509, 10% Henkel MM-6301.

EXAMPLE 4

(4) Four and Five Component Compositions: PPE, EMA, Modified SEBS, 4thand 5th component alloys. S. Auto- Haze Whit- L. Comp. clav (%) E(Kpsi)RF ening Temp Envir. S.Comp. A Yes 25 25 3 1 −25 Yes Yes B Yes 25 20 4 0−25 Yes Yes C Yes 20 25 4 0 −25 Yes Yes D Yes 25 25 4 0 −25 Yes Yes A.35% Soltex 4208, 45% EMAC2207, 10% Kraton RP6509, 10% Eastman PCCE9966.B. 30% Soltex 4208, 40% EMAC DS-1130, 10% Kraton RP6509, 15% PEU103-200,5% Eastman Ecdel 9966 C. 35% Soltex 4208, 40% EMAC DS1130, 5% KratonRP6509, 10% PEU103-200, 10% Kraton G1652. D. 35% Soltex 4208, 40%DS1130, 10% Kraton RP6509, 5% PEU103-200, 10% Kraton G1652.

EXAMPLE 5

(5) Four Component Compositions: PPE, EMA, modified SEBS, RF activityEnhancer Alloys. (more than 150 formulations). S. Auto- Haze Whit- L.Comp. clav (%) E(Kpsi) RF ening Temp Envir. S.Comp. A Yes 20 30 3 1 −20Yes Yes B Yes 20 25 3 0 −25 Yes Yes C Yes 20 20 4 0 −30 Yes Yes D Yes 2020 4 0 −30 Yes Yes E Yes 25 30 4 1 −25 Yes Yes F Yes 20 25 4 0 −30 YesYes G Yes >40 25 2 1 −20 Yes Yes A. 45% Fina 7825, 45% Chevron EMA (42%MA), 10% Morton PEU 192-100. B. 40% Soltex 4208, 40% Chevron EMAC2260,10% Shell Kraton RP6509, 10% PEU192-100. C. 35% Soltex 4208, 45%EMAC2260, 10% Shell Kraton RP6509, 10% PEU192-100. D. 35% Soltex 4208,45% EMAC2260, 10% Kraton G-1657, 10% PEU103-200. E. 40% Soltex 4208, 40%EMAC2220T, 10% Kraton RP6509, 10% PEU103-200. F. 35% Soltex 4208, 40%EMAC DS1130, 10% Kraton RP6509, 15% PEU103-200. G. 35% Mitsuit MAmodified PP AdmerSF700, 40% EMAC DS1130, 10% Kraton RP6509, 15%.PEU103-200.

EXAMPLE 6

(6) Four Component Compositions: PPE, ENBA, Modified SEBS alloys. S.Auto- Haze Whit- L. Comp. clav (%) E(Kpsi) RF ening Temp Envir. S.Comp.A Yes 25 30 2 0 −20 Yes Yes B Yes 25 30 2 0 −20 Yes Yes A. 40% Soltex4208, 40% Quantum ENBA80807 (35% BA), 10% Kraton RP6509, 10% PEU103-200.B. 40% Soltex 4208, 40% ENBA80808 (35% BA), 10% Kraton RP6509, 10%PEU103-200.

EXAMPLE 7

(7) Three and Four Component Compositions: PPE, Ethylene Vinyl Alcohol,polyamide, and Modified SEBS Alloys. S. Auto- Haze Whit- L. Comp. clav(%) E(Kpsi) RF ening Temp Envir. S.Comp. A Yes 35 45 4 1 −30 Yes Yes BYes 25 40 2 1 −30 Yes Yes C Yes 25 35 4 1 −30 Yes Yes D Yes 35 60 4 1−25 Yes Yes E Yes 30 35 4 0 −30 Yes Yes F Yes 25 45 4 0 −30 Yes Yes GYes 25 45 4 0 −30 Yes Yes A. 55% Soltex 4208, 5% EVALCA LCE151A, 40%Shell Kraton RP6509. B. 55% Soltex 4208, 5% EVALCA ES-G110A, 5% ShellKraton RP6509, 35% Shell Kraton 1652. C. 50% Soltex 4208, 5% EVALCALCE105A, 42% Shell Kraton RP6509, 3% PA-12. D. 72% Soltex 4208, 18%Kraton RP6509, 10% EVALCA G-115A. E. 55% Soltex 4208, 10% PA-12, 35%Kraton G1901X. F. 60% Soltex 4208, 5% PA-12, 35% Kraton RP6509. G. 60%Soltex 4208, 5% Versalon 1164, 35% Kraton RP6509.

EXAMPLE 8

(8) Three and four Component Compositions: PPE, EVA, Amide based TPE,EMAA compositions (Flexible component and RF component are the same). S.Auto- Haze Whit- L. Comp. clav (%) E(Kpsi) RF ening Temp Envir. S.Comp.A Yes 20% 20 4 0 −20C Yes Yes B Yes 30% 20 4 0 −25C Yes Yes C Yes 20 253 0 −25 Yes Yes D Yes 25 25 3 0 −25 Yes Yes E Yes 20 20 4 0 −30C Yes YesF Yes 30 30 4 0 −20 Yes Yes G Yes >50% ca.60 3 1 −20 Yes No H Yes >50%ca.50 4 1 −25 Yes No I Yes >50% ca.55 4 1 −20 Yes No J Yes >50% 46 3 1−25 Yes No K Yes >50% 40 4 1 −30 Yes No L Yes 25 25 3 0 −30 Yes Yes MYes 20 25 4 1 −25 Yes Yes O Yes 20 25 3 1 −30 Yes Yes P Yes 20 25 3 1−30 Yes Yes Q Yes 20 25 3 1 −30 Yes Yes R Yes 20 25 3 1 −30 Yes Yes A.35% Fina 7825, 55% Dupont Elvax 170 (36% VA), 10% Shell Kraton RP6509.B. 35% Soltex 4208, 55% Elvax 170, 10% Kraton RP6509. C. 40% Soltex4208, 50% Quantum UE659, 10% Kraton RP6509. D. 40% Soltex 4208, 50%UE634, 10% Kraton RP6509. E. 35% Soltex 4208, 40% UE659, 10% KratonRP6509, 10% Morton PEU 192-100. F. (more than 100 formulations), Fina,Soltex, BASF, REXENE PP's (45%), 45% Quantum UE644-04, 10% KratonRP6509. G. 50% PEBAX 4033, 35% Fina Z-7650, 15% Shell Kraton G1901X. H.50% PEBAX 4033, 20% Fina 8473, 20% K-1901X, 10% EVA (28% VA). I. 50%PEBAX 2533, 25% Fina 8473, 15% K-1901X, 10% EVA (28% VA). J. 60% PEBAX4033, 20% EVA (28% VA), 20% Shell Kraton G-1652. K. 60% PEBAX 4033, 20%PEBAX 2533, 20% EVA (28% VA). L. 30% Fina 7825, 60% Morton PEU 103-200,10% Shell Kraton RP6509. M. 35% Soltex 4208, 55 Chevron DS1009, 10%Shell Kraton RP6509. O. 45% Soltex 4208, 45% Dupont Nucrel (EMAA) 925,10% Shell Kraton RP6509. P. 45% Soltex 4208, 45% Dupont Nucrel −035. 10%Kraton RP-6509. Q. 45% Soltex 4208, 45% Dupont Evaloy EP4051 (ENBACO),10% Kraton RP-6509. R. 45% Soltex 4208, 45% Quantum UE648 (18% VA), 10%Kraton RP-6509.

EXAMPLE 9

(9) Three Component Compositions: PPE, EVA, Amide based TPE alloys(Flexible and High Temperature Resistance Components the Same). S. Auto-Haze Whit- L. Comp. clav (%) E(Kpsi) RF ening Temp Envir. S.Comp. C Yes25 30 3 0 −20 Yes Yes D Yes 35 30 2 0 −20 Yes Yes C. 45% REXENE FPO90007, 45% Elvax170, 10% Kraton RP6509. D. 60% FPO 90007, 30% EMAC (42%MA), 10% Shell Kraton RP-6509.

EXAMPLE 10

(10) Tafmer, homo, high amorphous content PP, and PP random copolymercompositions. S. Auto- Haze Whit- L. Comp. clav (%) E(Kpsi) RF eningTemp Envir. S.Comp. A No ca.25 22 0 0 −30 Yes Yes B Yes ca.20 31 0 0 −30Yes Yes C No ca.23 25 0 0 −30 Yes Yes A. 60% Tafmer A-4085, 40% Novolene1300L. B. 50% Tafmer A-4085, 10% Dypro8473, 40% Novolene 1300L. C. 50%Tafmer A-4085, 20% Dypro8473, 30% Novolene 1300L. Novolene is a highAmorphous content homo polypropylene by BASF, Dypro8473 is a randomcopolymer of propylene and ethylene of about 3.5% ethylene content byCosden (Fina).

EXAMPLE 11

(11) Tafmer, PP and Polybutene-1 alloys. S. Auto- Haze Whit- L. Comp.clav (%) E(Kpsi) RF ening Temp Envir. S.Comp. A Yes ca.25 17 0 0 −30 YesYes B Yes ca.30 35 0 0 −30 Yes Yes C Yes ca.30 15 0 0 −30 Yes Yes A. 30%Tafmer A-4085, 30% PB-8010, 40% Novolene 1300L. B. 50% Rexene 23M2, 25%PB-8010, 25% Tafmer A-4085. C. 40% Rexene 23M2, 30% PB-8010, 30% TafmerA-4085. Rexene 23M2 is a random Polypropylene ethylene copolymer ofabout 2% ethylene content. PB-8010 is a poly-butene ethylene copolymerby Shell Chemical.

1. A polymer based composition for fabricating into articles comprising:a low modulus radio frequency susceptible polymer having a modulus lessthan 30,000 psi, and in an amount by weight of 37-60% of thecomposition, the susceptible polymer having a dielectric loss greaterthan 0.05 at 1-60 MHz and ambient temperature to 250° C., thesusceptible polymer being selected from the group of ethylene copolymershaving 50-85% by weight ethylene content with a comonomer selected fromthe group consisting of acrylic acid, methacrylic acid, esterderivatives of acrylic acid with alcohols having 1-10 carbons, esterderivatives of methacrylic acid with alcohols having 1-10 carbons, andvinyl acetate; a temperature resistant polymer in an amount by weightfrom 30-60% of the composition and selected from the group consisting ofpolyamides, polyimides, polyurethanes, polypropylene, andpolymethylpentene; a compatibilizing polymer in an amount from 5-30% byweight of the composition, the compatibilizing polymer conferringcompatibility between the susceptible polymer and the temperatureresistant polymer, the compatibilizing polymer being a styrenic blockcopolymer with hydrocarbon soft segments; and wherein the compositionhas a mechanical modulus of less than 40,000 psi when measured accordingto ASTM D-882.
 2. The composition of claim 1 wherein the RF susceptiblepolymer is an ethylene methyl acrylate copolymer where the methylacrylate content is between 20-40%.
 3. The composition of claim 1wherein the temperature resistant polymer is a polyamide.
 4. Thecomposition of claim 3 wherein the compatibilizing polymer is a styreneethylene-butene styrene (“SEBS”) block copolymer.
 5. The composition ofclaim 1 wherein the temperature resistant polymer is a polypropylene. 6.The composition of claim 5 wherein the compatibilizing polymer is anSEBS block copolymer that is maleic anhydride functionalized.
 7. Apolymer based composition for fabrication into articles comprising: arandom copolymer of propylene and ethylene where the ethylene content iswithin the range of greater than 0 to about 6% by weight of thepropylene, the propylene copolymer being in an amount within the rangeof 30-60% by weight of the composition; a radio frequency (“RF”)susceptible polymer in an amount within the range of 30-60% by weight ofthe composition, the RF polymer being selected from the group ofethylene copolymers having 50-85% ethylene content with comonomersselected from the group consisting of acrylic acid, methacrylic acid,ester derivatives of acrylic acid with alcohols having 1-10 carbons,ester derivatives of methacrylic acid with alcohols having 1-10 carbons,and vinyl acetate; and a styrene ethylene-butene styrene block copolymerin an amount within the range of 5-30% by weight of the composition. 8.A polymer based composition for fabrication into articles comprising: aflexible heat distortion resistant polyolefin having a melting pointgreater than 130° C. and a modulus less than 20,000 psi, the polyolefinbeing in an amount within the range of 30-60% by weight of thecomposition; an ethylene methyl acrylate copolymer with a methylacrylate content within the range of 20-40%, the ethylene methylacrylate copolymer being in an amount within the range of 30-60% byweight of the composition; and a styrene ethylene-butene styrene blockcopolymer in an amount within the range of 5-30% by weight of thecomposition.